1. Field of the Invention
This invention relates to heart catherization and more particularly, to a closed system canulating device for canulating blood vessels, including arteries and veins and preventing uncontrolled blood flashback from the canulated needle. In a preferred embodiment the closed system canulating device includes a needle assembly, a reservoir having a tip attached to the hub of the needle assembly for containing 5-10 cc. of flashback blood, a wire guide provided in the interior of the reservoir and extending beyond the reservoir tip into the needle hub and a valve seated in the opposite end of the wire guide. The hub of the needle assembly may be shaped integrally with, or attached to the reservoir tip and the needle assembly and reservoir may be used to canulated an artery or vein and contain blood flashback in the reservoir. The reservoir remains in place on the needle assembly after canulation while the needle is in the vessel lumen, to contain pulsatile blood flashback and a catheter guide wire is inserted through the valve and wire guide, into the needle hub and through the needle into the artery or vein, to facilitate completion of the catherization procedure.
Catherization procedures, including left and right heart catherization, involve achieving vascular access by needle puncture. Once the needle has been canulated and positioned within the vessel lumen, a flexible guide wire can be advanced through the needle and well into the central vasculature. When this needle is withdrawn, the guide wire remains in the intravascular position and provides a means of introducing the desired catheter or catheters. Unfortunately, when the canulating needle is inserted into an artery, pulsatile blood flow is realized under relatively high pressure from the needle hub. This uncontrolled spurting of blood may strike the attending physician, as well as anyone else in the area.
Venous catherization can be performed through the femoral, internal jugular, subclavian or median antecubital vein, whereas arterial catherization can be accomplished through the femoral, brachial or axillary artery. At termination of the catherization procedure, the catheters and introducing sheaths are withdrawn and bleeding from the puncture sites is typically controlled by application of direct pressure.
The femoral artery and adjacent vein are the most commonly used vessels for percutaneous diagnostic cardiac catherization. The femoral artery typically lies at the midpoint of the inguinal ligament and can be palpated over a several centimeter span distal to the ligament. The femoral vein lies approximately one finger breadth medial to the artery, along a parallel course. Once the inguinal ligament and femoral artery have been identified, the femoral artery is palpated along its course using the three middle fingers of a left hand. With the lift hand remaining in place, transverse skin punctures are made over the femoral artery and vein using the tip of a scapel blade. The femoral artery is then punctured by inserting a needle through the lateral skin nick at about a 45 degree angle along the axis of the femoral artery, as palpated by the three middle fingers of the left hand. When the tip of the needle enters the lumen of the femoral artery, blood flashback is normally experienced responsive to pulsatile arterial blood flow. Since this blood typically spurts from the hub of the needle with considerable force and may strike the physician or assistant or both, who are standing beside the supine patient, the risk of spreading blood-bourne pathogens such as HIV virus (AIDS), hepatitis or syphilis, in non-exclusive particular, is present. The closed system canulating device of this invention is designed to collect and contain blood flashback as the tip of the needle enters the lumen of a vessel such as the femoral artery and during the catheter guide wire insertion procedure.
2. Description of the Prior Art
Various techniques have been used to produce or eliminate the flashback of blood from blood vessels such as arteries and veins during catherization procedures. U.S. Pat. No. 4,365,630, dated Dec. 28, 1982, to Richard H. McFarlane, discloses a "Flashback Chamber for Catheter". The patent details a plastic catheter having an improved flashback chamber to insure sequential filling with blood for visual observation of blood flow. A "Closed System Catheter With Guide Wire" is detailed in U.S. Pat. No. 4,652,256, dated Mar. 24, 1987, to Vincent L. Vaillancourt. The catheter system is designed for introduction and placement of a flexible catheter into the lumen of an artery or vein. A guide wire is provided for insertion through a hollow needle and the needle hub is provided with a skirt and extends through the hub and into flow communication with a flashback chamber. The guide wire is manipulated forwardly by grasping the wire and feeding the wire through the flashback chamber into the lumen after needle penetration has been made, as indicated by the blood flashback. U.S. Pat. No. 4,819,659, dated Apr. 11, 1989, to Dennis L. Sitar, details a "Blood Withdrawal Device With Movable Needle Guard Member". The unitary structure includes a tube-holding section and a locking section for locking a guard member in a permanently forward position, which covers the tip of the needle. A "Safety Catheter" is detailed in U.S. Pat. No. 4,828,548, dated May 9, 1989, to Gregary W. Walter. The safety catheter includes disposal apparatus for the safe disposal of a medicinal needle after use. The apparatus utilizes a container with a vacuum and a piston attached to one side of the needle which protrudes, ready for use. After use of the needle, one side of the piston is exposed to ambient pressure and the needle is retracted into the container for safe disposal. An "Intravenous Catheter Placement Device" is detailed in U.S. Pat. No. 4,944,728, dated Jul. 31, 1990, to Michael W. Carrell, et al. The intravenous catheter placement device includes a tubular catheter section concentrically surrounding an elongated tubular needle which has a bias cut point projecting from one end of the catheter section and used to lead the catheter section into a blood vessel. A protective sheath sub-assembly is connected to the needle and to the catheter section to facilitate withdrawal of the needle through the tubular catheter section into a protective, rigid tubular sheath, leaving the catheter section in place in the blood vessel. Locking elements on the protective tubular sheath sub-assembly lock the needle in the protective position. A "Single-Use Disposable Syringe" is detailed in U.S. Pat. No. 4,955,871, to Ronny D. Thomas. The syringe includes a reservoir formed of two sheets of thermoplastic material having expanded central portions that form a pair of convex domes, both of which are compressible, and a connecting member which spaces the domes. In response to complete compression of both of the central portions together, the reservoir substantially collapses and each of the domes becomes concave, to prevent the reservoir from being reformed and undesirable re-use of the syringe. After partial compression of both the central portions together and partial collapse of the reservoir, the central portions expand to reform the reservoir and draw fluid into the reservoir, therby aspirating a hypodermic needle. U.S. Pat. No. 5,030,207, dated Jul. 9, 1991, to Stephen H. Mersch, et al, details an "Instaneous Vein Entry Indicator for Intravenous Needle". The device indicates when an intravenous needle has entered a vein, by use of a solid fiber optic mounted in the needle for showing visual instaneous vein entry. The distal end of the fiber optic is polished for flush positioning with the distal point of the needle and the fiber optic is sized to include an outer diameter which will extend through the cannula of the needle. This polished distal end reflects color, such as red blood, immediately upon vein entry and exposure of blood to the magnifying system forming a part of the invention at the rear, or proximal end of the fiber optic. The user observes immediate vein entry without any blood flow or exposure to blood.
It is an object of this invention to provide a closed system canulating device for canulating a blood vessel and containing flashback of blood from the vessel upon entry of the needle into the vessel.
Another object of this invention is to provide a closed system canulating device for canulating an artery or vein and facilitating insertion of a catheter guide wire through the canulating needle without spreading pulsatile blood from the artery or vein.
A still further object of this invention is to provide a closed system canulating device for canulating an artery or vein and preventing uncontrolled spurting of blood from pulsatile blood flow, which canulating device includes a flashback blood receptacle attached to a canulating needle and fitted with a wire guide and valve for receiving a catheter guide wire and containing flashback pulsatile blood flow after the needle has entered the lumen of the artery or vein.
Yet another object of the invention is to provide a closed system canulating device which includes a canulating needle having a hub connected to or shaped integrally with a reservoir for containing flashback blood, a hollow wire guide extending longitudinally through the reservoir and terminating in the needle hub and a self-sealing, resilient hemostatic valve located in the wire guide for sealing a catheter guide wire in the wire guide as the catheter guide wire is inserted in the wire guide, needle and into the lumen of a canulated blood vessel. The wire guide may be spaced from the needle canula or lumen inside the needle hub or seated against the needle lumen and fitted with one or more slots or openings to facilitate flashback blood flow from the blood vessel through the needle lumen and into the reservoir.